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The Accu-Chek Inform Meter is designed to quantitatively measure the concentration of glucose in whole blood samples. The device is indicated for use by health care professionals and persons with diabetes mellitus.

The Accu-Chek Inform Meter is an addition to the Accu-Chek brand of blood glucose monitors that incorporates the fundamental scientific technology currently found in the Accu-Chek Advantage Meter and Accu-Chek Complete Meter. The Accu-Chek Inform Meter is designed for use in conjunction with either the Accu-Chek Advantage or Accu-Chek Comfort Curve test strips.

The Accu-Chek Inform system is addition to the Accu-Chek brand of blood glucose monitors that incorporates the fundamental scientific technology currently found in the Accu-Chek Advantage Meter. The Accu-Chek Inform Meter is a modification to the Accu-Chek Advantage Meter that involves integrating the AccuData GTS unit's data gathering features into the meter. The modification does not affect the device's intended use. The Accu-Chek Inform Meter may be used in conjunction with the same test strips indicated for use with the Accu-Chek Advantage Meter, and the test principle described on the following page is not affected by the design modifications. This modification can be accomplished due in part to the availability of palmtype computers (PDA). Our product designers modified the Accu-Chek Advantage Meter by building into its body an off-the-shelf PDA. The PDA module enabled our designers to integrate the AccuData GTS unit's data gathering features into the meter itself. The Accu-Chek Inform Meter was designed to be convenient and easy to use.

The provided text describes a Special 510(k) submission for the Accu-Chek™ Inform® Meter, which is a modification of an existing device (Accu-Chek Advantage Meter). Therefore, the study presented focuses on demonstrating substantial equivalence to the predicate device, rather than establishing de novo performance criteria for the modified device.

As a result, the document does not contain information on discrete acceptance criteria and a detailed study explicitly proving the device meets those criteria in the way a new device would. Instead, it asserts that the modifications to the Accu-Chek Advantage Meter, primarily involving integrating data gathering features into the meter, do not affect the fundamental scientific technology, intended use, indications for use, or analytical performance claims.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document as distinct, quantifiable acceptance criteria with corresponding performance results. The submission relies on the assertion that "Meter model does not significantly affect analytical performance claims" and "Meter model does not significantly affect method comparison results" as compared to the predicate device.

2. Sample size used for the test set and the data provenance

This information is not provided. The document states that analytical performance and performance comparisons are "Derived from testing with the two test strips listed above. Claims are stated in test strip package inserts." This implies that the performance data originates from studies conducted on the test strips themselves, which are compatible with both the predicate and the modified device, rather than a specific new study for the Accu-Chek Inform Meter. No details on the sample size or provenance for this underlying test strip data are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. As the submission focuses on substantial equivalence based on the predicate device's established performance with associated test strips, there's no mention of a new test set requiring expert ground truth establishment for the modified meter itself.

4. Adjudication method for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is a blood glucose meter, not an AI-assisted diagnostic imaging or analysis tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not directly applicable or provided in the context of an algorithm-only performance study. The device is a meter that measures glucose concentration; its "performance" is inherently tied to its ability to accurately measure blood glucose. The submission states the meter's software converts electrical signals to glucose values, and that "Meter model does not significantly affect analytical performance claims." This implies the "standalone" performance of the measurement system (meter + test strip) is considered equivalent to the predicate.

7. The type of ground truth used

The type of ground truth for blood glucose measurements is generally established through comparison to a laboratory reference method. The document states, "The system's correlation to a comparative laboratory method is established by the manufacturer." However, specific details about the nature of this "comparative laboratory method" are not provided in this summary.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" in the context of this device, as it's a quantitative measurement device rather than a machine learning model that would typically require a training set.

9. How the ground truth for the training set was established

This information is not provided and is not applicable for the reasons mentioned above.

In summary, this 510(k) submission leverages the established performance of its predicate device and compatible test strips. It explicitly states that the modifications (integration of data management features) do not alter the fundamental scientific technology, intended use, or analytical performance. Therefore, detailed new studies with specific acceptance criteria and performance data for the modified device are not presented because the argument for substantial equivalence rests on the lack of impact of the modifications on these critical performance aspects.

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